EMA Says Yes To GSK’s Omjjara, UCB’s Rystiggo and Novartis’ Spexotras
Three orphan drugs were among the eight products recommended for pan-EU marketing approval by the European Medicines Agency this week, while Novartis withdrew its filing for Vijoice.
You may also be interested in...
Vertex’s Casgevy has made history as the world’s first approved CRISPR gene editing therapy after the UK’s MHRA authorized the medicine ahead of its US and European regulatory counterparts.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency has recommended the conditional approval of Mirati’s lung cancer drug Krazati following a re-examination of its initial negative opinion.